Stroke Patients Discharged from Hospital Sooner when Administered Revalesio's RNS60; New Statistically Significant Finding from Revalesio's Phase 2 Clinical Trial

Reduced hospital stays with more patients discharged to home when treated with RNS60

Results presented during oral presentation at the American Academy of Neurology 2025 Annual Meeting

TACOMA, Wash., April 9, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new data from its completed Phase 2 RESCUE clinical trial of RNS60 in acute ischemic stroke patients, demonstrating that patients were discharged on average 4.8 days sooner (p=0.022) from the hospital following treatment with RNS60 plus standard of care endovascular thrombectomy (EVT) than patients who received an EVT alone. Patients who received RNS60 also experienced a reduction in infarct volume growth (brain tissue loss) post-EVT by more than 50% (p<0.05).  These results were presented during an oral presentation at the American Academy of Neurology (AAN) 2025 Annual Meeting being held in San Diego, CA from April 5-9, 2025.

"There is a lot of discussion currently taking place on improving human health while lowering the cost of healthcare. Given RNS60's Phase 2 results showing reduced brain tissue loss, improved function, and reductions in both hospital stay and the need for long-term care, RNS60 has the potential to greatly benefit patients and their families while lowering the economic burden of stroke," said Bert van den Bergh, Revalesio's Executive Chairman of the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company.

"Revalesio's choice to capture infarct growth post-EVT is a great example of how Phase 2 clinical trials should be designed to properly evaluate cytoprotective drugs with the use of imaging to confirm results," said David S. Liebeskind, M.D., Director of the Neurovascular Imaging Research Core at UCLA. "I congratulate the investigators and Revalesio on their results and look forward to seeing RNS60 in a Phase 3 trial."

Oral Presentation

Highlights from the oral presentation to include:

• RNS60 high dose significantly lowered infarct growth by 50% (p<0.05)
• Subjects treated with RNS60 high dose were discharged 4.8 days sooner from the hospital (p=0.022)
• 55% of subjects treated with RNS60 high dose were discharged to their home compared to 21% of subjects treated with placebo
• 72% of subjects on RNS60 high dose were independent compared to 37% on placebo based on dichotomized modified Rankin Scale (0-2) at Day 90
• RNS60 was safe and well tolerated

"Our Phase 2 trial results sum up a decade's worth of research where the consistency in results has been remarkable.  In preclinical models of stroke and traumatic brain injury, RNS60 reduced brain loss by up to 50%," said Greg Archambeau, President of Revalesio and co-inventor of RNS60.  "Upon a potential FDA approval, we will be ready to rapidly scale our specialized U.S. manufacturing capability for RNS60 so patients won't have to wait."

About the RESCUE Phase 2 Clinical Trial

In RESCUE, a multi-center, double-blinded, placebo-controlled, randomized Phase 2 clinical trial, Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and received intravenous RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of the EVT and continuing for 48 hours.

The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study evaluated disability based on the well-established modified Rankin Scale (mRS), change in the size of the stroke as measured by MRI at 48 hours, and additional endpoints including Barthel Index, NIHSS, and EQ-5D-5L.

About RNS60

RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis.

About Revalesio

Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life.

For more information, please visit revalesio.com and engage with us on LinkedIn.

Media:
Lori Murray
[email protected]

SOURCE Revalesio Corporation